Senior Director, Clinical Operations

Keros Therapeutics•Lexington, MA

About The Position

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients. Job Summary As the leader of the cross-functional Clinical Program Team, the Senior Director Clinical Operations (SDCO) will lead the planning and execution strategy of assigned clinical trials to achieve overall program and corporate objectives. The SDCO will lead an assigned team internally as well as designated CRO/vendors. The SDCO will represent operational perspectives at the cross functional Program Team (or similar) ensuring high quality, feasible trials are planned with clear timelines, budget and deliverables. The SDCO will drive operational excellence through process improvement, sharing best practices, and proactive planning. The SDCO is the primary point of escalation for resolution of trial management operational issues. This role will interact with the Clinical Development leadership and is expected to present at leadership meetings. The SDCO may have direct reports.

Requirements

15+ years of clinical operations experience within the biotech/pharmaceutical/CRO sector(s)
Phase 1/2/3 global clinical study experience.
5+ years of people management, including Associate Director level
Experience in rare and/or advanced diseases
Understanding of FDA, EMEA, GDPR, ICH and GCP regulations and guidelines.
BA/BS in a clinical or scientific discipline.

Nice To Haves

Experience in pediatric and/or neuromuscular disorders

Responsibilities

Independently leads and manages the cross-functional Program Team to ensure deliverables are met within the established timelines, budget and quality/compliance standards.
Represents clinical operations at external and internal meetings related to assigned clinical topics.
Determines the clinical vendor strategy for assigned studies/program; participates in the evaluation and selection of vendors, develops scope of work.
Oversees and manages e.g. Associate Director, Clinical Project Managers and/or other resources.
Serves as escalation point for clinical vendors.
Represents clinical program at internal governance meetings.
Contributes to the development of clinical trial documents by providing operational expertise and input to ensure efficient, high quality, executable clinical protocols are approved.
Responsible to ensure clinical trial protocol(s) go through all internal review and approval processes.
Guides the development of trial related materials and scientific trial related documents (e.g. charters, training and patient recruitment materials.
Contributes to the safety and data review plans for studies.
Actively contributes to site and country feasibility, strategy and selection.
Guides the team to overcome obstacles and managing study risks through risk identification, mitigation planning, proactive team communication and creative problem solving.
Ensure Good Clinical Practice and inspection readiness across studies.
Develop and oversee implementation of corrective actions to support good data quality.
Study budget management including forecasting and review of accruals and contract management.
Contributes to the development and assessment of Key Performance Indicators/Metrics
Identifies areas for new/refined processes within and outside of clinical operations.
Initiates projects that help to create and refine the clinical operations organization.